Prevention of Malaria With Dihydroartemisinine + Piperaquine for Forest Rangers (PREMAL)

Oxford University Clinical Research Unit, Vietnam

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Drug: Arterakine (DHA/piperaquine); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02788864

17MA

Details and patient eligibility

About

The purpose of the study is to assess if the antimalarial drugs Dihydroartemisinine + Piperaquine (DP) are effective in preventing malaria infection for forest ranger

Full description

To assess the protective effect of 3-day DP regimen for forest rangers working for long-term in forest where malaria transmission is intense, all eligible forest rangers will be treated with a full course of DP + primaquine to eradicate all parasites which may survive in their blood while staying in non- malaria transmission areas.

Just before returning back to the forest participants will be randomized to receive either Arterakine (dihydroartemisinine (DHA)/piperaquine) (intervention arm) or placebo (control arm). Participants will be assessed for parasitemia before and after the forest trip with high volume, ultrasensitive, PCR (HVUqPCR). The minimum time span between two forest trips should be 20 days so participants could complete the 14 day primaquine course and the Arterakine (dihydroartemisinine (DHA)/piperaquine).

There is no limit in the duration between trips. Participants are tested for P.falciparum, P.vivax infection before they return to the forest.

Each participant will be visited 2 weeks or later after returning home from the forest and examined. The rationale for the added two weeks is to detect blood stages of infections, which may have been inoculated towards the end of the forest visit.

If found to be sick, the patient will be treated according to government treatment guidelines. A 4ml venous blood sample will be obtained for Hb and HVUSqPCR.

Enrollment: 150 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Informed consent
2. Male, over or equal to18 years of age
3. Able and willing to comply with the study requirements and follow-up

Exclusion criteria

1. Inability to tolerate oral treatment
2. Previous episode of haemolysis or severe haemoglobinuria following primaquine
3. Glucose-6-phosphate dehydrogenase (G6PD) deficient with Hb < 9 g/dL *
4. Known hypersensitivity or allergy to any study drugs * If the participant with G6PD deficient gets malaria, primaquine would be used as recommended by World Health Organization (WHO) (once a week for 8 weeks) in combination with 3 days of chloroquine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Arterakine

Active Comparator group

Description:

Active drug: Arterakine (DHA/piperaquine) one tablet contains 40 mg of dihydroartemisinin and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinin; 55 mg/kg piperaquine phosphate) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)

Treatment:

Drug: Arterakine (DHA/piperaquine)

Placebo

Placebo Comparator group

Description:

Placebo (visually matched to Arterakine for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)

Treatment:

Drug: Placebo